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Ticagrelor Removal Study Using CytoSorb® 300 mL Device During CPB in Patients Undergoing Emergent Cardiothoracic Surgery (CyTation)

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ClinicalTrials.gov Identifier: NCT04625764
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : November 4, 2021
Sponsor:
Information provided by (Responsible Party):
CytoSorbents Europe GmbH

Brief Summary:
The aim of CyTation is to demonstrate intra-operative removal of ticagrelor by CytoSorb® hemadsorption in patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB, using platelet reactivity to adenosine diphosphate (ADP) as a pharmacodynamics surrogate measure of ticagrelor levels in blood.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Procedure: Blood sampling and analysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open, Multi-center, Single-arm Study to Demonstrate the Feasibility of the CytoSorb® 300 mL Device to Remove Ticagrelor During Cardiopulmonary Bypass in Patients on Ticagrelor Undergoing Emergent Cardiothoracic Surgery
Actual Study Start Date : February 23, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

Arm Intervention/treatment
Experimental: patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB Procedure: Blood sampling and analysis
Blood sampling for pharmacokinetics (Plasma ticagrelor concentrations and its metabolite) and MEA platform testing (ADPtest, TRAPtest)




Primary Outcome Measures :
  1. Platelet reactivity [ Time Frame: 8 hours ]
    Proportion of patients with post-operative platelet reactivity to ADP above the level associated with increased bleeding risk (≥ 22 ADP-induced platelet aggregation units (AUC in units)) measured on the MEA platform immediately after CPB compared to immediately before CPB.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Males and females aged ≥18 years
  • Patients treated with ticagrelor
  • Emergency Coronary Artery Bypass Graft (CABG) surgery
  • Cardiothoracic surgery requiring CPB ≤24 hours following the last dose of ticagrelor

Exclusion Criteria:

  • Any cardiothoracic surgery >24 hours after last dose of ticagrelor
  • Resuscitation
  • Any pre-operative coagulopathy unrelated to ticagrelor or standard of care (SoC) to undergo surgery with CPB
  • Sepsis (according to Sepsis 3.0 definition)
  • Malignant tumor
  • Left ventricular ejection fraction (LVEF) < 20%
  • History or presence of significant pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurologic, or psychiatric disease which, in the opinion of the Investigator, increases risk to the patient or could confound the results of the study
  • Presence of end-stage renal disease or currently receiving renal replacement therapy
  • Patients with a history of major organ transplantation
  • Patients in acute sickle cell crisis
  • Patients concurrently requiring immunosuppressive therapy, with the exception of corticosteroids, or who are profoundly immune suppressed (e.g. CD4 < 200 or neutropenia with ANC < 1000/μL)
  • Women of childbearing potential with a positive pregnancy test performed during the current admission or who are lactating. Women are considered not of child bearing potential if they have been sterilized at least 6 months prior to the study or if they are post-menopausal, defined as amenorrhea for at least 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04625764


Contacts
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Contact: Sven Giersdorf, Ph.D. +49 30 65499145 clinical@cytosorbents.com

Locations
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Germany
University Hospital Essen Recruiting
Essen, Germany, 45147
Contact: Matthias Thielmann, Prof. MD         
Principal Investigator: Matthias Thielmann, Prof. MD         
Asklepios Hospital St. Georg Hamburg Recruiting
Hamburg, Germany, 20099
Contact: Kambiz Hassan, MD         
Principal Investigator: Kambiz Hassan, MD         
University Hospital Jena Recruiting
Jena, Germany, 07747
Contact: Mahmoud Diab, MD         
Principal Investigator: Mahmoud Diab, MD         
Luxembourg
Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle Recruiting
Luxembourg, Luxembourg, 1210
Contact: Klaus Kallenbach, Prof. MD         
Principal Investigator: Klaus Kallenbach, Prof. MD         
Sponsors and Collaborators
CytoSorbents Europe GmbH
Investigators
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Principal Investigator: Kambiz Hassan, M.D. Asklepios Kliniken Hamburg gGmbH, Asklepios Klinik St. Georg, Abteilung für Herzchirurgie/ Chefarzt Prof. Michael Schmoeckel, Lohmühlenstr. 5, 20099 Hamburg/Germany
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Responsible Party: CytoSorbents Europe GmbH
ClinicalTrials.gov Identifier: NCT04625764    
Other Study ID Numbers: CSI17
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CytoSorbents Europe GmbH:
Cardiopulmonary bypass
CPB
Ticagrelor removal
CytoSorb
Platelet reactivity
MEA platform test
Intensive care medicine
Hemadsorbtion
Extracorporeal blood purification
Coronary Artery Bypass Grafting
CABG
Cardiac Surgery
Aortic valve replacement
Mitral valve replacement
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases